India’s drug regulator approves Moderna’s vaccine for emergency use: Report
India’s drug regulator has granted drugmaker Cipla permission to import Moderna’s Covid-19 vaccine for restricted emergency use in the country, news agency PTI reported on Tuesday quoting unnamed official sources .
In a separate communication, Moderna has informed that the US has agreed to donate a certain number of doses of its Covid-19 vaccine through Covax to the Government of India for use here has sought approval from the Central Drugs Standard Control Organisation (CDSCO), while Cipla, on behalf of the US pharma major, has requested for import marketing authorization of these jabs.
Cipla filed an application on Monday seeking permission for import of Moderna’s Covid-19 vaccine referring to DCGI notices dated April 15 June 1 as per which if the vaccine is approved by the USFDA for EUA, the vaccine can be granted marketing authorisation without bridging trial assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization programme.
Also, the requirement of testing of every batch by the Central Drugs Laboratory (CDL), Kasauli can be exempted if the batch/lot is released by the CDL of country of origin.
However, summary lot protocol review scrutiny of documents shall be undertaken by the laboratory for batch release as per standard procedures, Cipla said referring to the DCGI”s new revised rules.
Moderna through a separate communication has informed that the US Government has agreed to donate a certain number of doses of the Moderna Covid-19 Vaccine, mRNA-1273, through Covax to the Government of India for use in India has submitted the dossiers through e-mail.
“This correspondence is to request the CDSCO to open a file for approval of these urgently needed vaccines,” Moderna said.
(Only the headline picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
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